Biopsy needle system, biopsy needle and method for obtaining a tissue biopsy specimen

ABSTRACT

A biopsy needle system includes a carrier. A trocar is inserted into the carrier for percutaneous insertion to a biopsy site. A biopsy needle is inserted into the carrier, replacing the trocar, for removal of a tissue biopsy specimen. A biopsy needle and a method for obtaining a tissue biopsy specimen with the system, are also provided.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a biopsy needle system, a biopsy needle and amethod for obtaining a tissue biopsy specimen with the system.

2. Description of the Related Art

The most critical diagnosis in medicine is the presence or absence ofmalignancy. Although there are many screening tests: patient awareness,physical exams, blood tests, and new imaging systems, the hallmark ofthe cancer diagnosis is a physical specimen, or biopsy, for microscopicanalysis.

Malignancy is of life or death importance, so that the quality of thebiopsy is of utmost importance. Open surgical biopsy, with total controlof specimen location, size, and condition, is the accepted standard ofdiagnostic quality and a minimally invasive, percutaneous or endoscopicbiopsy must not sacrifice that quality, since a false negative maycondemn the patient to an agonizing and preventable death.

Obtaining tissue is more difficult by any remote biopsy technique, butquality still relies on obtaining tissue of and from the suspected mass.Therefore, location of needle placement, tissue coring and preserving ofthe biopsy specimen are of critical importance.

New imaging systems improve needle placement, but with prior art biopsyneedles, the actual capture of the biopsy specimen remains unsure andpartially blind. The complex multi-motion sequencing of the typicalside-cut biopsy needle is so demanding on operator skill, that evenautomation has not made it totally reliable.

A simple, one-motion, true end-cutting, core biopsy needle, whichcleanly and safely shear-cuts straight ahead from the initial approachpositioning, yet not blindly, would be an advancement in the art.

Endoscopic biopsy graspers and percutaneous biopsy needles generallyrecover limited, thin, short, slivers of tissue, making microscopicanalysis and diagnosis difficult. An end-cutting, core biopsy needle,which recovers full-lumen specimens of almost unlimited length, would bean advancement in the art.

With the prior art, the biopsied tissue is frequently ripped,compressed, distorted or even crushed, limiting analysis and diagnosis.Fine needle aspiration biopsy, where the tissue is intentionally rippedinto small segments or even single cell clusters, is so destructive tointracellular and intercellular anatomy that it is unwise to use thattechnique as any more than a screening test. Their cytology debrisfields are of such poor condition, that although they can occasionallyinclude the diagnosis of malignancy, they seldom exclude it.

An end-cutting, core biopsy needle that is totally non-traumatic totissue and preserves intracellular and intercellular anatomy would be anadvancement in the art.

SUMMARY OF THE INVENTION

It is accordingly an object of the invention to provide a biopsy needlesystem, a biopsy needle and a method for obtaining a tissue biopsyspecimen, which overcome the hereinafore-mentioned disadvantages of theheretofore-known devices and methods of this general type, which areminimally-invasive, percutaneous or endoscopic and which not only exceedthe prior art, but more importantly match the quality of an opensurgical biopsy. The system, needle and method should be simple to use,easy to insert and control, reliable, safe, biopsy-depth adjustable,straight-ahead shearing, end-cutting, automatic-capture, longerfull-lumen specimen, tissue-preserving, and over all a core biopsyneedle system, a biopsy needle and a method for percutaneous andendoscopic use that improve biopsy quality.

With the foregoing and other objects in view there is provided, inaccordance with the invention, a biopsy needle system. The systemcomprises a carrier, a trocar to be inserted into the carrier forpercutaneous insertion to a biopsy site and a biopsy needle to beinserted into the carrier, replacing the trocar, for removal of a tissuebiopsy specimen. The trocar and the biopsy needle are longer than thecarrier, permitting a distal end of the trocar or the biopsy needle toextend beyond a distal end of the carrier. The system uses the trocar tostrengthen the carrier upon initial insertion and relocation of thecarrier and permits the needle to be inserted at the correct locationand for cutting of the specimen only.

In accordance with another feature of the invention, the biopsy needlehas a distal end with a cross-sectional shape having a flat side and aconverging side. The converging side has a-semicircular, elliptical,oval, rounded, trapezoidal, paraboloid or triangular shape, althoughother shapes are possible as well.

In accordance with a further feature of the invention, the biopsy needlehas a distal end, a lumen and a door disposed within the lumen at thedistal end. The door is moveable freely about a hinge location from anormally open position lying at least partially against the flat sideduring percutaneous insertion, to a rotated and closed positioncontacting the converging side occluding the lumen and capturing thetissue biopsy specimen. The door has a fixed portion with a forward edgetapered and sharpened to decrease tissue passage entrance resistance.The door has a door tip opposite the hinge location for contacting theconverging side and occluding the lumen. The tip is tapered andsharpened on a side facing away from the lumen and is turned down orangled toward a center of the lumen. The tip of the door is angled intothe lumen to catch and dig into the tissue biopsy specimen uponretraction of the biopsy needle. Thus, an automatic door for catchingand removing a tissue biopsy specimen is provided, which requires noother operation or manipulation other than advancement and retraction.

In accordance with an added feature of the invention, the biopsy needlehas a distal end with a tissue cutting entrance, which is preferablyangled relative to a longitudinal axis of the biopsy-needle. The tissuecutting entrance advances into the tissue biopsy specimen permitting thecore to contact the door.

In accordance with an additional feature of the invention, there isprovided a hinge interconnecting the flat side and the door at the hingelocation. The hinge may be an articulating hinge, a tension-compressionor live one-piece functional hinge, or a torsion element live orone-piece functional hinge. The hinge permits the door to swing awayahead of the specimen core and close behind it to obtain a tissue biopsyspecimen.

In accordance with yet another feature of the invention, the door has atleast one and preferably two flexing areas functioning as a hinge, whichmay be formed by cutting into the door, in particular in a pattern ofseparation lines. The flexing areas preferably each extendperpendicularly to the longitudinal direction of the door. This providesgreat flexibility of the door without an articulating hinge.

In accordance with yet a further feature of the invention, the door tipis angled into the lumen at one of the flexing areas closest to the doortip and is tapered and sharpened on a side facing away from the lumen,to catch and dig into the tissue biopsy specimen upon retraction of thebiopsy needle.

In accordance with yet an added feature of the invention, the trocar hasa tapered point protruding from the carrier.

In accordance with yet an additional feature of the invention, thetrocar and the carrier have distal ends with cross-sectional shapesmatching the cross-sectional shape of the biopsy needle. The mostsuitable of the above-mentioned cross-sectional shapes can be used forall three devices, the trocar, the carrier and the biopsy needle.

In accordance with again another feature of the invention, the carrier,the biopsy needle and the trocar each have at least one control ring.The carrier has a proximal end with a conically shaped or taperedentrance facilitating introduction of the biopsy needle and the trocarinto the carrier. The control rings and the conical or tapered entrancefacilitate operation and manipulation by an operator.

In accordance with again a further feature of the invention, the carrierhas an outer surface with etched markings of insertion length. Themarkings aid in percutaneous insertion placement.

In accordance with again an added feature of the invention, there isprovided a controller to be fitted on the biopsy needle, after insertionof the biopsy needle into the carrier, for adjustably gauging biopsydepth. The controller has a multiplicity of fitting regions eachpermitting a different biopsy depth. The controller is block-shaped andthe fitting regions are slots or holes formed in the block-shapedcontroller having different lengths. The controller provides a simpleway of adjusting cutting depth, with the longest depth being without useof the controller and decreasing depths being provided through use ofthe different fitting regions.

In accordance with again an additional feature of the invention, thereis provided a syringe to be locked to the biopsy needle, after insertionof the biopsy needle into the carrier, for applying a vacuum to assistin tissue migration into the biopsy needle. The biopsy needle has asyringe connector, and the syringe has an end matching the syringeconnector. The syringe connector and the end of the syringe are taperedconically. The syringe has a syringe plunger to be pulled out and lockedfor applying the vacuum. The syringe has a syringe body with a lip orpeak, and the plunger has notches to be locked on the lip or peak. Thesyringe may be preloaded with a fluid, such as saline, to fill thebiopsy needle while evacuating air and facilitate formation of a vacuumseal upon insertion of the biopsy needle and extraction of the tissuebiopsy specimen. The vacuum syringe aids in extraction of the specimenand allows the specimen to be removed without being disturbed by manualmanipulation of the operator.

With the objects of the invention in view, there is also provided abiopsy needle. The biopsy needle comprises a lumen, and a door disposedat the lumen. The door is moveable freely about a hinge location from anormally open position during percutaneous insertion, to a rotated andclosed position occluding the lumen and capturing a tissue biopsyspecimen for removal. All of the features of the biopsy needle of thebiopsy needle system can be used in the biopsy needle apart from theother features of the system. For example, the cross-sectional shapes,the tapered and sharpened forward edge and tip of the door, the tissuecutting entrance, the hinges and the flexing areas may all be used aswell.

With the objects of the invention in view, there is additionallyprovided a method for obtaining a tissue biopsy specimen. The methodcomprises inserting a trocar into a carrier, inserting the carrier withthe trocar percutaneously to a biopsy site, removing the trocar from thecarrier, inserting a biopsy needle into the carrier, and removing thetissue biopsy specimen with the biopsy needle. This method is simple touse, accurate and obtains a quality specimen. The rotation of the door,the decrease in tissue passage entrance resistance with a tapered andsharpened forward edge of the door, the flexing of the door, thecatching and digging into the tissue biopsy specimen with the door tipand the movement of the door within the cross-sectional shapes, are allpart of the method of the invention.

Other features which are considered as characteristic for the inventionare set forth in the appended claims.

Although the invention is illustrated and described herein as embodiedin a biopsy needle system, a biopsy needle and a method for obtaining atissue biopsy specimen, it is nevertheless not intended to be limited tothe details shown, since various modifications and structural changesmay be made therein without departing from the spirit of the inventionand within the scope and range of equivalents of the claims.

The construction and method of operation of the invention, however,together with additional objects and advantages thereof will be bestunderstood from the following description of specific embodiments whenread in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagrammatic, partially elevational and partiallyperspective view of a biopsy needle system according to the invention;

FIG. 2 is a side-elevational view of a biopsy needle of the systemaccording to the invention;

FIG. 3 is a side-elevational view of a trocar of the system according tothe invention;

FIG. 4 is a side-elevational view of a carrier of the system accordingto the invention;

FIG. 5 is a side-elevational view of the biopsy needle inserted into thecarrier;

FIG. 6 is a side-elevational view of the trocar inserted into thecarrier;

FIG. 7 is a side-elevational view of the biopsy needle inserted into thecarrier, with a depth controller therebetween;

FIG. 8A is a perspective view of the trocar inserted into the carrier;

FIG. 8B is a perspective view of the biopsy needle inserted into thecarrier;

FIG. 9 is a fragmentary, greatly enlarged, cross-sectional view of adistal end of the biopsy needle with a rotating door in an openposition;

FIG. 10 is a view similar to FIG. 9 with the rotating door in a closedposition;

FIGS. 11A-11E are end-elevational views of the distal end of the biopsyneedle showing different cross-sectional shapes;

FIG. 12 is a further enlarged, front-elevational view of the rotatingdoor with a flexing area;

FIGS. 13 and 14 are views similar to FIG. 12 of the rotating door withtwo flexing areas;

FIGS. 15 and 16 are perspective views of the rotating door with twoflexing areas in different flexing positions;

FIGS. 17A and 18A are respective perspective and side-elevational viewsof the rotating door having an articulating hinge in a non-rotatedposition;

FIGS. 17B and 18B are respective perspective and side-elevational viewsof the rotating door having the articulating hinge in a rotatedposition;

FIGS. 19A and 19B are enlarged, perspective views of a controller of thesystem according to the invention;

FIGS. 20A, 20B and 20C are enlarged, perspective views showing a syringeof the system according to the invention in three positions with andwithout the biopsy needle; and

FIGS. 21A and 21B are side-elevational views of the assembled carrier,controller, biopsy needle and syringe, in two different positions of thecontroller.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the figures of the drawings in detail and first,particularly, to FIG. 1 thereof, there is seen a biopsy needle systemaccording to the invention which has a biopsy needle 1, a trocar 40, acarrier 50, a controller 60 and a syringe 70. More specifically, thefive-piece system includes:

-   -   a. an integrated, reliable, true end-cutting, full-lumen        specimen, coring, biopsy needle 1;    -   b. an integrated, easy-insertion, biopsy needle carrier trocar        40;    -   c. an integrated, improved-placement, high-reflectance,        easy-insertion, biopsy needle carrier 50;    -   d. an integrated, single-piece, dual-use, adjustable biopsy        depth gauge and depth controller 60; and    -   e. an integrated, dual-use, lockable, vacuum-assisted, coring        and non-traumatic specimen removal syringe 70.

As is seen in FIG. 2, the biopsy needle 1 is formed as a tube-likestructure, constructed of metal or other suitable material with aproximal end 2 (at the left in the figure) toward the operator and adistal end 3 (at the right in the figure) toward the object tissue. Theproximal end 2 has a permanently attached control ring 4 for operatorcontrol, mounted over a tapered reinforcing collar 5, which alsoincludes an inline, full size lumen-matching syringe connector 6continuous with the needle lumen. The lumen is defined as all of thespace or the passage or channel within a tube. The distal end 3 has asharpened double angled, shear cutting edge tissue entrance 7, formed orangled at approximately 45 degrees from a centerline or longitudinalaxis 15 and is constructed for an improved straightforward, non-blind,core cutting and capture of a tissue biopsy. This structure of angledcutting surfaces creates a shearing edge, as opposed to a right angle orstraight across edge, which has increased cutting resistance and crushestissues of very firm or soft consistencies. The distal end 3 with thetissue entrance 7 will be described in more detail below with regard toFIGS. 9 and 10.

As is seen in FIGS. 11A-11E, the tissue entrance 7 of the biopsy needle1 is constructed with unique cross-sectional shapes. These shapes allhave one flat side or section 8 covering of approximately one third ofthe circumference of the tissue entrance 7 and opposing walls coveringapproximately two thirds of the remaining circumference and havingsymmetrical, constantly closing angle wall configurations from the flatside 8, to close the tube or needle 1.

These opposing walls of the structural shapes, which are important tothe invention, include a converging side 9 forming a semicircle in FIG.11A, converging sides 10 forming an ellipse or oval in FIG. 11B,converging sides 11 forming a pure or rounded trapezoid in FIG. 11C,converging sides 12 forming a paraboloid in FIG. 11D, and symmetricalconverging straight sides 13 forming a triangular shaped tube or needlein FIG. 11E.

Each of these shapes and similar ones with converging walls are used inthe invention depending on needle type, intended use, length, size,operator preference, tissue type and tissue consistency. As will beexplained below with regard to a door 20 of the invention, theconverging wall shapes shown in FIGS. 11A-11E allow for continuous andsimultaneous door to lumen wall occlusion, door rotation stoppage,complete tissue severing, uniform door edge support and reliablespecimen capture.

The straight or flat side 8 provides a flat area for permanentattachment of a fixed half of a hinge to the rotating hinged door 20.This end-cutting door 20, which is located just inside the distal tissueentrance 7, as is seen in FIGS. 9 and 10, is the part of the inventionwhich allows for automatic end cutting of the needle biopsy corespecimen.

A fixed or nonmoving portion 21 of the door 20 has a forward (lumenside) edge 22 which is tapered and sharpened to decrease tissue passageentrance resistance. The hinged door 20 moves freely about a hingelocation 23 from its normally open position shown in FIG. 9 in which itlies against the straight wall or flat wall segment 8 during insertion,to an opposite extreme of being fully rotated and closed against theopposing wall or converging side 9-13 as is seen in FIG. 10, totallyoccluding the passageway or lumen 14 and capturing the biopsy tissue.

The hinged door 20 and the converging walls or sides 9-13 work incombination to form and function as the long sought after, trueend-cutting biopsy needle. The constantly converging walls or sides 9-13form a continuous and simultaneous shearing occlusion between the lumen14 and the lumen-shaped door 20. This hinged door 20 is contoured to fitthe lumen 14 perfectly at about a 35 to 45 degree arc segment of theneedle lumen or on a line running approximately 35 to 45 degrees from acenterline of the lumen, as is seen in FIG. 10. The distal end 3 of theneedle tube is formed at approximately a 40 to 50 degrees angle and thehinged door 20 stops or occludes at roughly 5 to 15 degrees of rotationshort of the end of the needle. The door 20 intentionally impacts theopposing or converging lumen walls or sides 9-13 uniformly and issupported along the entire circumference, stopping and shearing, withoutany other operator action, mechanical parts or latches. Further doorrotation or pass through failure is prevented.

This structure according to the invention has been developed because ithas been found that with non-converging angle walls, such as with asquare tube, there is no uniform contact or shearing, the door isunevenly supported, being held only at the hinge and opposite wall. Thedoor flexes centrally, shortens, and over rotates, with pass throughdoor failure and tissue specimen loss.

Three separate embodiments of hinge structures may used in theend-cutting door 20 according to the invention, depending on needlesize, length, intended use, operator preference, tissue type and tissueconsistency.

First is a macro-machined or formed, common articulating hinge 47provided at the hinge location 23, where two or more pieces rotate 48,49 in relation to each other at, around, or as, a joint. The joint isprovided with a standard axle element and interlacing fingers, such asin a typical door or piano hinge, or one piece 48 may be in the shape ofan eye and the other piece 49 may be in the shape of a hook, cooperatingwith each other, as is seen in FIGS. 17A, 17B, 18A and 18B. These hingesdemonstrate high flexibility and a large range of motion, but havehigher resistance to tissue passage into the lumen 14 because of theirincreased bulk. They are more difficult to manufacture economically,suffer more binding between the parts with a greater tendency towardfailure to the hinge or even worse, hinge separation failure, than withthe other embodiments.

Second is a micro-machined or formed, tension/compression live hingewhere an area 24 of the door material itself flexes and becomes afunctional hinge. This bending or flexing area 24 of door material maybe thinned, narrowed, lengthened, or separated into two or more activehinge segments to improve flexibility of the bending area. The hingeelement shaping or separation area 24 has lines 25 generally formed orcut at right or high angles of 45 to 90 degrees to a hinge or flexingaxis as is seen in FIG. 12. Opposing, top and bottom surfaces of thislive hinge structure are alternately placed in tension and compression.These functional hinges show higher initial strength with more limitedflexibility, lower cycle tolerances and higher failure rates due tomolecular strain and disruption in the area of tension, than the otherembodiments. Lengthening or broadening the hinge area 24 improvesflexibility but if the flexing area 24 is broadened in the hinge to tipdimension, the longer flexing area 24 causes the door length and fit tothe lumen walls to change. More problems are experienced than with theother embodiments, especially with changes of tissue consistency, withunpredictable occlusion against the opposing wall with either prematureor incomplete closure to over rotation and pass through of the intendedsupport angle and door failure.

Third is a micro-machined or formed torsion live hinge where an area 28of the door material itself flexes and becomes a functional hinge. Thisflexing area may be separated into two or more active hinge elementareas 28, 29, generally by micro-machining or laser cutting, to improveflexibility, widen the flexing area, decrease molecular strain andimprove reliability. The illustrated flexing areas extendperpendicularly to a longitudinal direction of the door, between thehinge location 23 and the tip 35. However, it is merely a manipulationof the angle, length, width, overlap and pattern, of the formedseparations which converts the tension/compression areas into improvedfunction, torsion areas. The hinge areas 28, 29 have separation lines30, 32 that are formed or cut generally parallel to, or at low angles of0 to 45 degrees to, the hinge or joint axis, as is seen in FIGS. 13, 14,15 and 16. The lines 30 have holes 31 at the end for preventing tearingas is seen in FIGS. 13 and 16. The lines 32 shown in FIGS. 14 and 15 aregenerally S-shaped with angles of 90 degrees within the S and severalstraight segments 33 toward the periphery, so that most lines extendacross a greater region in the direction from hinge to tip of the door20 than the straight lines 30.

Opposing surfaces of these overlapping hinge areas 28, 29 arealternately placed in bi-directional or shared torsion, which not onlyhas low molecular strain or disruption but also less flexing resistance.Narrowing, lengthening, or varying the overlap or shape of theindividual torsion areas 28, 29 by the form or pattern of cuts of thelines 30, 32 or by adding additional torsion zones, can improveflexibility and further reduces molecular strain. This structure isfunctionally reliable, dimensionally stable, has high flexibility, highcycle capability, high strength, low heat build up, low moleculardistortion and low failure rates. This hinge structure works well with abroad range of tissue types and consistencies.

Another important feature of the end-cutting door 20, is the structureof a distal door tip 35, opposite from the hinge location 23. This tip35 is tapered and sharpened on the side 36 facing away from the distalend 3 of the lumen 14, and is turned down or angled toward the center ofthe lumen as is seen in FIGS. 15 and 16. The second or additionalflexing area 29 facilitates the tip 35 to flex away from the inwardpassing tissue and also flex into the outwardly passing tissue. Thesefour features are combined and adjusted to act as a catch or barb, tohook into the tissue specimen as the tissue attempts to reverse itsmovement in relation to the needle 1, when the biopsy needle 1 is movedrearward or away from the area of biopsy. The tissue plug or specimen,still being connected to its organ system, will be held by its owntissue cohesion and attempt to remain in place as the needle iswithdrawn, with the tissue being pulled out of the needle 1 unless thedoor tip 35 intervenes.

This door tip 35 is constructed to be automatic in function. Atinsertion, the tip 35 allows the tissue to pass without restriction intothe needle 1, but upon the first rearward movement of the tissue, thetip catches and digs into the tissue. Cutting into and across thespecimen, which continues the further rotation of the door 20 until itstrikes the opposing contour fitting or converging walls or sides 9-13uniformly and simultaneously severing or end cutting and capturing thetissue core of biopsy specimen.

The biopsy specimen is now safely trapped within the lumen 14 and heldby the automatic door 20 for easy and non-traumatic removal. Just thesimple act of insertion cleanly shear-cuts or cores the specimen andjust as simply withdrawal automatically hooks, end cuts, severs, andcaptures the biopsy specimen. The end-cutting door 20 is freely moveablewithin its controlled range and needs no separate activation by theoperator or automation. The structure of the hinge location 23 and thedigging-in movement of the turned down distal door tip 35 create all thedoor rotational forces.

The important structural elements of the biopsy needle include:

1. The biopsy needle 1 having an inline, full size lumen-matchingsyringe connector 6 at the proximal end 2, which is continuous with theneedle lumen 14 for vacuum application and specimen removal and atapered re-enforcement 5 for fitted engagement with the biopsy needlecarrier 50.

2. The distal end 3 having a sharpened, double angled, shear cuttingtissue entrance 7 formed at approximately 45 degrees from the centerlinefor straight forward, non-blind shearing of a core biopsy specimen.

3. The needle 1 being constructed of several functionally importantstructural cross-sectional shapes, with one side 8 being straight orflat and opposing walls being symmetrical, constantly closing angle orconverging walls or sides 9-13 joining and forming the needle tube.

4. The distal end 3 having a hinged, end-cutting door 20, with a fixed,non-moving, hinge location 23 being permanently affixed to the flat side8, and its tissue facing forward edge 22 being tapered and sharpened.The hinged door 20, rotating from its open or position of repose againstthe flat wall side 8, allowing the tissue into the lumen 14, to theclosed position, against and occluding with, the opposing walls or sides9-13, where the combination of the two complementary shaped surfacescome together to sever and capture the biopsy specimen.

5. The hinge structures include an articulating hinge, atension-compression or live one-piece functional hinge and a torsionelement live or one-piece functional hinge.

6. The tip 35 of the hinged door 20 being tapered and sharpened on theside 36 facing away from the distal end 3 of the lumen 14, coupled withthe tip 35 of the door being angled into the lumen and with theadditional hinging area 29 to catch and dig into the specimen on itsrearward movement. By intention, this angled portion causing furtherrotation of the door 20 through and severing the specimen upon impactionand occlusion with the opposing walls or sides 9-13 and capturing of thespecimen.

The biopsy needle and trocar carrier 50 seen in FIG. 4 is a tube-likestructure with a permanently attached reinforcing area 51 and doublegrasping control rings 54, 55 surrounding a proximal end 52, toward theoperator, with a tapered entrance channel 56 to facilitate and protectthe insertion of the trocar 40 or biopsy needle 1 into the positionsshown in FIGS. 7 and 8, respectively. A distal end 53 has a right angleor straight across termination, which is tapered and has a sharpenededge around its entire circumference, to aid insertion into the subjecttissue.

The biopsy needle carrier 50 is constructed of metal or other suitablematerial, in matching variations of lengths from 8 cm to 40 cm and inequivalent cross-sectional diameters of 10 to 18 gauge. The carrier 50has cross-sectional shapes matching the biopsy needles 1 and trocars 40,but is slightly larger, since the carrier is constructed to fit snugglyover the biopsy needle as seen in FIG. 8B or over the trocar as seen inFIG. 8A, for ease of introduction through the body layers and to safelycontain and support the biopsy needle 1 to the proper location andanglulation, for beginning the biopsy coring, done by the biopsy needle1, through the carrier 50. The biopsy needle carrier 50 and the trocartip 41 have a smooth contour for insertion and penetration of layers, asis seen in FIGS. 3, 4, 5, 6, 7, 8A and 8B.

The important structural features of the carrier 50 include:

1. The biopsy needle carrier 50 having a conically shaped or taperedentrance 56 to the lumen at the proximal end 52 for facilitating theintroduction of the biopsy needle 1 and trocar 40 without abrasion,damage or dulling of their sharpened edges.

2. The biopsy needle carrier 50 matching the cross-sectional shapes ofthe biopsy needle 1 and trocar 40.

3. The biopsy needle carrier 50 being intentionally shorter than thebiopsy needle 1 by four centimeters as is seen at the right side ofFIGS. 5 and 8, providing for precise adjustability of biopsy depth in 1centimeter increments, from 4 cm down to 1 cm in length.

4. The biopsy needle carrier 50 having tissue-penetrating smooth walls,seen in FIG. 4.

The biopsy needle carrier trocar 40 seen in FIG. 3 is configured andconstructed of a suitable material to act as an insertion andstrengthening aid for the biopsy needle carrier 50. In percutaneousbiopsy, there are several layers of tissue which the biopsy system mustpass through, in order to reach the biopsy site and since suchrelatively large bore needles cannot be made with cutting tips becauseof tissue damage, a tapered and pointed central lumen filler, or trocar40 with a control ring 42, must be added to assist insertion.

The biopsy needle 1 is also relatively long and is maneuvered duringinsertion with bends and angle changes. These leverages or bendingforces also require the stabilizing and strengthening of the needlecarrier 50 with a full size strong trocar 40. The trocar 40 isconstructed to fit snuggly within the lumen of the biopsy needle carrier50, matching the carrier in size, cross-sectional shape and beingslightly longer in length with a finely tapered point 41 that protrudesfrom the carrier 50 as is seen in FIGS. 3 and 6.

Insertion of the relatively large bore round object through multiplefibrous layers meets with an exaggerated resistance related to thephenomenon of pressure desiccation or drying and stretching by thecompression of tissue layers ahead of the trocar 40 and carrier 50.

The forced advancement of the encased round trocar 40 drives the normalinterstitial fluid from the contacting tissue and stretches the fibrouslayers, creating a collapsing, tightening, fibrous tube surrounding thecarrier 50 and trocar 40, much like a Chinese finger trap. Thispronounced increase in resistance takes significant pressure toovercome, decreases the tactile feel or proprioceptive feedback to theoperator and increases the risk of misplacement orbreak-through-over-insertion trauma to other organ systems.

The trocar 40 and carrier 50 are inserted and maneuvered as a singleunit. Between biopsies, performed by the biopsy needle 1, the trocar 40is reinserted within the carrier 50 for any repositioning or anglechange of the carrier. The objective is to insert and maneuver thecarrier 50 to the perfect depth and position, with the tip of thecarrier just at the beginning of the planned biopsy tract and at theproper angle for insertion of the biopsy needle 1, with predictable, notblind, straight ahead core cutting of the tissue of interest. The biopsyneedle carrier 50 is also constructed with etched markings 58 ofinsertion length, in centimeters, on its outer lateral surfaces for moreprecise placement, as is seen in FIGS. 4-7.

A single-piece, dual-use, four-separate-depth, adjustable biopsy depthgauge and depth controller 60 is shown in detail in FIGS. 19A and 19B.The controller is provided in recognition of the importance of having atthe operators' option, a method to gauge and control the depth of thebiopsy to protect contiguous organ systems. The carrier 50 is placedwith great intention in proper position, relation, and angle to thetarget tissue and with the biopsy needle 1 being 4 cm longer than thecarrier 50. Thus, a desirably safe, simple, easy to use, one-piecemethod to gauge and control the reach or depth of the biopsy needle 1beyond the carrier 50 is presented.

The domino-shaped clip-on or slide-on controller 60 according to theinvention, which contains three separate, measured, dual use sides,shown in FIGS. 19A and 19B, satisfies this requirement. The depth gaugeand biopsy depth controller, configured with the dual-use system,includes a multiplicity of fitting regions, namely three self-graspingfitted slots 61, 62, 63 constructed for convenient snap-on, after needleinsertion or changing depth use and three matching, fitted holes 64, 65,66, for preplanned and more secure slide-on use. Without the controller60, the extension beyond the carrier or biopsy coring will be 4 cm indepth, if clipped or fitted on the side with the shortest dimension 67,3 cm in depth, if clipped or fitted on the side with the middledimension 68, 2 cm in depth and if clipped or fitted on the side withthe longest dimension 69, 1 cm in depth. The mounting of the controller60 between the needle 1 and the carrier 50 can be seen in FIG. 7. Theclip-on, slide-on gauge becomes a simple, effective and safe structureto gauge and control biopsy depth.

A lockable, vacuum-assisted, coring and non-traumatic specimen removalsyringe 70 is shown in FIGS. 20A, 20B and 20C. The syringe provides thedesirable option to the operator of a method for vacuum assisted biopsycoring. Tissues of extremely firm or soft consistencies are difficult toadvance cleanly into a biopsy needle lumen and is the most common causeof biopsy recovery failure. The application of a continuous vacuumthroughout the coring insertion pulls or assists the tissue migrationinto the needle lumen 14. Once the biopsy needle 1 is inserted throughthe carrier 50, and sealed against the target tissue, the lockablevacuum-pulling syringe 70 is attached to the biopsy needle syringeconnector 6 using a larger-than-lumen, tapered and matching conicallyshaped end 71 as is seen in FIG. 20B, and the vacuum is applied bypulling out and locking a syringe plunger 72. Of course, the controller60 may be disposed between the biopsy needle 1 and the carrier 50 in anyof its positions, two of which are shown in FIGS. 21A and 21B, dependingon the desired depth of penetration, as described above.

Another important structural feature of the locking syringe isinterlocking counter-angled edges. The edges firstly include a narrow,upwardly-angled lip or peak 74 around the top of a syringe body orcylinder 75, and secondly downwardly-angled notches 73 formed in thelower third of four blade-shaped columns 76 of the plunger 72 of thesyringe 70, three of which are seen in FIG. 20 c. An operational featureis that the syringe comes preloaded with normal saline to fill thebiopsy needle 1 while evacuating the air, to provide a more effectivevacuum seal upon insertion and extraction of the specimen.

Once vacuum is applied, the plunger 72 is moved off center as is shownin FIG. 20A, engaging and locking the two counter-angled edges 73, 74,which are now held in the locked position by the force of thepre-selected vacuum. The biopsy needle 1 is then advanced with vacuumassisted coring of the biopsy specimen. The vacuum is automaticallyreleased upon withdrawal, with exposure to the atmosphere.

The dual-use ability comes from the large needle to syringe connector 6and the residual vacuum of coring. Upon withdrawal, the atmosphericpressure automatically and non-traumatically pushes the cored specimeninto the vacuum and specimen recovery syringe 70. The biopsy specimen,contained within the syringe, can then be released over an absorbentcloth by the operator and transferred with non-grasping instruments intothe pathology container and preservative. The untouched biopsy specimenis maintained in perfect condition. The biopsy is completed and qualityis assured.

The integrated, complete, and all-inclusive biopsy system is constructedfor multidisciplinary use. Its availability in sizes (from 10 to 18equivalent gauge) and lengths (from 8 cm to 40 cm) makes it suitable formany biopsy techniques and procedures. The hinge and needle shapevariations, with the option of vacuum assistance, create a compatibilitywith many tissue consistencies or organ systems. Its increasedreflectivity and visibility, compatible to new imaging technologies,yield a level of control, depth and angle precision not previously seen.

The invention provides a true end-cut tissue biopsy, equaling thequalities of an open surgical biopsy, but using a minimally invasivetechnique.

Improved, minimally invasive biopsies are now available for fieldsincluding, but not limited to, the following:

-   -   a. unguided, percutaneous needle biopsy, as in obvious, palpable        subsurface solid masses;    -   b. manually or finger-guided, percutaneous biopsy, such as        transrectal, or transperineal prostatic needle biopsy, etc.;    -   c. visually-guided, open surgical needle biopsy with an exposed        mass or tissue;    -   d. visually-guided, trans-orifice biopsy such as oral, nasal,        tracheal, or rectal needle biopsy, etc.;    -   e. remotely or virtually-visualized, and guided percutaneous        needle biopsies of internal organ systems, such as breast, lung,        kidney or liver biopsy, etc.;    -   f. endoscopically-guided, percutanous or trans-instrumental        needle biopsy of internal organs such as bladder, prostate,        bronchial, esophagus, sigmoid, etc.;    -   g. laproscopically guided trans-abdominal, percutaneous or        trans-instrumental, needle biopsy of internal organs, including        ovary, bowel, uterus or unknown masses, etc.; and    -   h. for tissue confirmation of many non-malignant medical        conditions.

1. A biopsy needle, comprising: a one-piece body having a distal enddefining a biopsy needle lumen, said distal end having a distal edgetissue cutting entrance of said one-piece body with a cross-sectionalshape having a flat side extended transversely to a longitudinal axis ofthe biopsy needle and at least one converging side forming a shapeselected from the group consisting of semicircular, elliptical, oval,rounded trapezoidal, paraboloid and triangular; a door disposed at saidlumen, said door having a flat portion fitting said flat side of saiddistal edge tissue cutting entrance and at least one converging portionfitting said at least one converging side of said distal edge tissuecutting entrance; a hinge location of said one-piece body at said flatside of said distal edge tissue cutting entrance; and a hinge disposedat said hinge location; said door being moveable freely back and forthabout said hinge, and said door being moveable about said hinge merelydue to percutaneous insertion and percutaneous withdrawal of the needle,from a normally open position during percutaneous insertion, to arotated and closed position totally occluding said lumen between saidsides and said portions and automatically capturing a tissue biopsyspecimen for removal.
 2. The biopsy needle according to claim 1, whereinsaid door lies at least partially against said flat side in saidnormally open position, and contacts said converging side in said closedposition.
 3. The biopsy needle according to claim 1, wherein said doorhas a fixed portion with a forward edge tapered and sharpened todecrease tissue passage entrance resistance.
 4. The biopsy needleaccording to claim 1, wherein said door has a door tip opposite saidhinge location for contacting said converging side and occluding saidlumen.
 5. The biopsy needle according to claim 4, wherein said tip istapered and sharpened on a side facing away from a distal end of saidlumen and is turned down or angled toward a center of said lumen tocatch and dig into the tissue biopsy specimen upon retraction of thebiopsy needle.
 6. The biopsy needle according to claim 1, wherein saiddistal end tissue entrance is angled other than 90° relative to saidlongitudinal axis of the biopsy needle.
 7. The biopsy needle accordingto claim 1, wherein said hinge is an articulating hinge interconnectingsaid flat side and said door at said hinge location.
 8. The biopsyneedle according to claim 1, wherein said hinge is a tension-compressionor live one-piece functional hinge interconnecting said flat side andsaid door at said hinge location.
 9. The biopsy needle according toclaim 1, wherein said hinge is a live or one-piece functional torsionelement hinge interconnecting said flat side and said door at said hingelocation.
 10. The biopsy needle according to claim 1, wherein said doorhas at least one flexing area functioning as said hinge and formed bycutting into said door.
 11. The biopsy needle according to claim 10,wherein said at least one flexing area is formed by a pattern ofseparation lines cut into said door.
 12. The biopsy needle according toclaim 10, wherein said door has a door tip opposite said hinge locationdefining a longitudinal direction of said door between said door tip andsaid hinge location, and said at least one flexing area is two flexingareas each extending perpendicularly to said longitudinal direction ofsaid door.
 13. The biopsy needle according to claim 12, wherein saiddoor tip is angled into said lumen at one of said flexing areas closestto said door tip and is tapered and sharpened on a side facing away froma distal end of said lumen, to catch and dig into the tissue biopsyspecimen upon retraction of the biopsy needle.
 14. The biopsy needleaccording to claim 1, wherein said distal edge tissue entrance has aclosed cross-sectional shape surrounding said lumen.
 15. The biopsyneedle according to claim 1, wherein said distal edge tissue entrancehas a circumference and said flat side is disposed at saidcircumference.